Evaluating the Effectiveness of an Individualized Nutrition and Physical Activity Counseling Program

Breast Cancer Clinical Trial

Official title:

Evaluating the Effectiveness of an Individualized Nutrition and Physical Activity Counseling Program on Body Weight, Composition, Cardiovascular Function and Quality of Life in Breast Cancer Survivors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04365569
• Other study ID #: CASE11119
• Status: Recruiting
• Phase: N/A
• Start date: January 6, 2021
• Est. completion date: December 1, 2024

Study information

• Verified date: June 2024
• Source: Case Comprehensive Cancer Center
• Contact: Elizabeth Stone, MD
• Phone: +1 954-659-5840
• Email: stonee[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

More than 65% of breast cancer survivors are overweight and less than one-third participate in recommended levels of physical exercise. Obese breast cancer survivors have been found to have greater than a two-fold increase in mortality compared to women with normal body mass index (BMI). The current standard for weight loss interventions involves in-person counseling. However, this incurs costs related to travel for counseling sessions, potentially limiting program participation, compliance and sustainability.This is a pilot study of an individualized in-person and telephone-based nutrition and exercise counseling program.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Breast cancer diagnosis (stage 0-III)

• Body mass index of 25mg/k2 or greater

• Actively being followed by medical oncologist, radiation oncologist, and/or breast surgeon at Maroone Cancer Center

• Able and willing to participate in nutrition counseling at Maroone Cancer Center

• Able (cleared by participant's primary oncologist) and willing to perform cardiopulmonary exercise testing

• Participants must have the ability to understand and the willingness to sign a written informed consent document

• Performance status 0 or 1 as per ECOG scale [see Appendix IV]

Exclusion Criteria:

• Body mass index below 25kg/m2

• No prior history of breast cancer

• History of metastatic disease

• Not being followed by medical oncologist, radiation oncologist, and/or breast surgeon at Maroone Cancer Center

• Unable or unwilling to participate in nutrition counseling at Maroone Cancer Center

• Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

• Participants actively undergoing chemotherapy, immunotherapy or radiation treatment. However, participants currently taking hormonal therapy, such as selective estrogen receptor modulators (SERMS), or aromatase inhibitors, may be included in the study.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Nutrition and physical activity counseling program
6-month interventional, counseling program based on nutrition and physical activity consisting of: 1. Nutritional counseling by a Registered Dietitian (RD) 2) Implementation of an adequate physical activity program

Locations

Country	Name	City	State
United States	Cleveland Clinic Florida Weston, Case Comprehensive Cancer Center	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life as measured by Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)	Quality of life as measured by Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B), a 36-item self-report questionnaire to assess the quality of life as reported by breast cancer survivors with scores ranging from 0 to 123, and lower scores indicating better health.	Baseline, 3 months and 6 months
Other	Quality of life as measured by Brief Pain Inventory (BPI)	Quality of life as measured by Brief Pain Inventory (BPI), a 9-item self-administered questionnaire that can evaluate the effect of an individual's pain on their daily functioning. This is a 10-point scale with 0 being the best possible score, meaning "no pain", and 10 being the worst possible score, meaning "pain as bad as you can imagine"	Baseline, 3 months and 6 months
Other	Quality of life as measured by Generalized Anxiety Disorder-7 (GAD-7)	Quality of life as measured by Generalized Anxiety Disorder-7 (GAD-7), a 7-item self-report questionnaire measuring anxiety which uses a four-point rating scale (ranging from 0 to 3) asking how often in the last two weeks participants have experienced symptoms pertaining to feeling anxious, worried, difficulty relaxing, and irritability. Higher scores indicate higher distress. with a possible score range of 0 to 21 with higher scores indicating worse anxiety.	Baseline, 3 months and 6 months
Other	Quality of life as measured by Patient Health Questionnaire-9 (PHQ-9)	Quality of life as measured by Patient Health Questionnaire-9 (PHQ-9), which objectifies degree of depression severity with a possible score range of 0 to 27 and higher scores indicating worse outcomes	Baseline, 3 months and 6 months
Other	Quality of life as measured by NCCN Distress Thermometer	Quality of life as measured by NCCN Distress Thermometer, which measures distress on a scale of 0 to 10, with higher scores indicating worse distress	Baseline, 3 months and 6 months
Other	Factors associated with adherence to the program	Factors to be assessed include age, race, time since diagnosis, time since last chemotherapy, medical comorbidities and other lifestyle factors such as alcohol consumption and smoking	At 6 months
Primary	Percent of participants achieving 10% weight loss	Efficacy of intervention as assessed by percent of participants achieving 10% weight loss	At baseline
Primary	Percent of participants achieving 10% weight loss	Efficacy of intervention as assessed by percent of participants achieving 10% weight loss	At 3 months
Primary	Percent of participants achieving 10% weight loss	Efficacy of intervention as assessed by percent of participants achieving 10% weight loss	At 6 months
Primary	Compliance to the recommended dietary pattern	Assess compliance to the recommended dietary pattern, diet quality scores will be calculated by the RD after monthly telephone consults or in-person at 3 months and 6 months into the intervention. Each of the 3 elements will be scored from 0-3, resulting in a total score range from 0-9	At 3 months
Primary	Compliance to physical activity goal	Percent of participants complying with proposed activity goal of 150 minutes of moderate intensity physical activity or 75 minutes of vigerous intensity physical activity (or a combination of both) per week over six months	At 6 months
Secondary	Body fat percentage	Body fat percentage measured by the registered dietitian (RD) using bioelectrical impedance analysis	Baseline
Secondary	Body fat percentage	Body fat percentage measured by the registered dietitian (RD) using bioelectrical impedance analysis	3 months
Secondary	Body fat percentage	Body fat percentage measured by the registered dietitian (RD) using bioelectrical impedance analysis	6 months
Secondary	Glycemic control as measured by HbA1c	Glycemic control as measured by HbA1c	At 3 months
Secondary	Glycemic control as measured by HbA1c	Glycemic control as measured by HbA1c	At 6 months
Secondary	Cholesterol	Effect of the intervention on lipid profile as measured by high density cholesterol levels	At 3 months
Secondary	Cholesterol	Effect of the intervention on lipid profile as measured by high density cholesterol levels	At 6 months
Secondary	Low density lipoprotein	Effect of the intervention on lipid profile as measured by low density lipoprotein levels	At 3 months
Secondary	Low density lipoprotein	Effect of the intervention on lipid profile as measured by low density lipoprotein levels	At 6 months
Secondary	high density lipoprotein	Effect of the intervention on lipid profile as measured by high density lipoprotein levels	At 3 months
Secondary	high density lipoprotein	Effect of the intervention on lipid profile as measured by high density lipoprotein levels	At 6 months
Secondary	Triglycerides	Effect of the intervention on lipid profile as measured by triglyceride levels	At 3 months
Secondary	Triglycerides	Effect of the intervention on lipid profile as measured by triglyceride levels	At 6 months
Secondary	Serum vitamin D	Effect of the intervention on serum vitamin D	At 3 months
Secondary	Serum vitamin D	Effect of the intervention on serum vitamin D	At 6 months
Secondary	Serum C-reactive protein (CRP)	Effect of the intervention on CRP	At 3 months
Secondary	Serum C-reactive protein (CRP)	Effect of the intervention on CRP	At 6 months
Secondary	Maximum oxygen uptake as measured by VO2 max	Maximum oxygen uptake as measured by VO2 max	Baseline
Secondary	Maximum oxygen uptake as measured by VO2 max	Maximum oxygen uptake as measured by VO2 max	At 3 months
Secondary	Maximum oxygen uptake as measured by VO2 max	Maximum oxygen uptake as measured by VO2 max	At 6 months